Vascular Graft Recall Due to Swivel Rod Separation
Atrium Medical is recalling the ADVANTA VXT vascular graft due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. This component separation could affect device function.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall of a critical surgical implant with reported component separation. No hospitalizations or injuries have been reported in the source. The hazard poses a risk of device malfunction in a high-risk anatomical context, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Atrium Medical Corporation is recalling the ADVANTA VXT, 6X50, 1GDS, FH, STR-SW vascular graft, a single-ended slider device used in vascular procedures. The recall was issued following complaints of separation between the Slider GDS Swivel Rod and the Swivel Core, with a notable gap observed between the two pieces.
This component separation poses a risk that the vascular graft may not perform as intended during or after surgical placement, potentially compromising the integrity of the implant.
Approximately 53,308 units have been distributed worldwide, with 11,236 units in the United States (including Puerto Rico) and 42,072 units distributed internationally across more than 60 countries.
Healthcare providers and patients with questions should contact Atrium Medical Corporation. If you have received this implant and have concerns, contact your physician immediately.
The recalled product
- Product
- ADVANTA VXT, 6X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular Graft
- Hazard
- component-separation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Product Code: 22062
- UDI-DI: 00650862220629.
Distribution
Distributed nationwide across the United States.
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